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510(k) K071338

FLEX ARM RETRACTOR SYSTEM by Koros USA, Inc. — Product Code GZT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 29, 2007
Date Received
May 14, 2007
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Retractor, Self-Retaining, For Neurosurgery
Device Class
Class II
Regulation Number
882.4800
Review Panel
NE
Submission Type

Other clearances by Koros USA, Inc.

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  • K082399 — PECTUS STRUT (November 5, 2009)

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  • K161318 — Phantom Fukushima Neurological Holding Systems, Phantom Mastability Neurological (March 20, 2017)
  • K161004 — Self-retaining Retractor (September 9, 2016)
  • K150378 — NICO BrainPath & Accessories, NICO BrainPath, NICO Shepherd's Hook (June 12, 2015)
  • K120691 — BRAIN PORT (June 5, 2012)